Rectal CancerNCT03413930
Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
A study testing Transanal total mesorectal excision and Laparoscopic total mesorectal excision in people with Rectal Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Transanal total mesorectal excision and Laparoscopic total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jun 2019to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years < age < 80 years
- Body mass index (BMI) <30 kg/m2
- Tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection)
- Pathological rectal carcinoma
- Clinically diagnosed cT1-3N0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
- Tumor size of 5 cm or less
Show all 9Show fewer
- ECOG score is 0-1
- ASA score is Ⅰ-Ⅲ
- Informed consent
Who cannot join
- Requiring a Mile's procedure
- Fecal incontinence
- History of inflammatory bowel disease
- Pregnant woman or lactating woman
- Severe mental disease
- Intolerance of surgery for severe comorbidities
Show all 9Show fewer
- Previous abdominal surgery
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer
- Requirement of simultaneous surgery for other disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer
This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.
Read the detailed description
Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present，surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Transanal total mesorectal excision, Laparoscopic total mesorectal excision
- Keywords
- TaTME, Rectal cancer, Laparoscopic Surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal total mesorectal excisionProcedure or surgery
Patients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）
Laparoscopic total mesorectal excisionProcedure or surgery
Patients undergo Laparoscopic total mesorectal excision.
| Study group | Role | What they receive |
|---|---|---|
| TaTME | Experimental | Patients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA） Receives: Procedure: Transanal total mesorectal excision |
| LaTME | Active comparator | Patients with mid or low rectal cancer undergo laparoscopic total mesorectal excision. Receives: Procedure: Laparoscopic total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumferential resection margin (CRM)
Positive rate of circumferential resection margin (pathological assessment)
Measured: 14 days after surgery
Secondary outcomes (11)
Completeness of mesorectum
Pathological assessment of completeness of the TME specimen（complete, near
Measured: 14 days after surgery
Lymph node detection
Lymph nodes harvested（numbers）
Measured: 14 days after surgery
Distal safety margin
Length of distal margin （millimeter，mm）
Measured: 14 days after surgery
Operative time
Operative time（minutes）
Measured: Intraoperative
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Measured: Intraoperative
Length of stay
Duration of hospital stay（days after surgery）
Measured: 1-30 days after surgery
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Measured: 1-14 days after surgery
Early morbidity rate
Morbidity rate 30 days after surgery
Measured: 30 days
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge
Measured: 1-3 days after surgery
3-year disease free survival rate
3-year disease free survival rate
Measured: 36 months after surgery
5-year overall survival rate
5-year overall survival rate
Measured: 60 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study startJun 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2026 (estimated)
Why it stopped: No funding was raised
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Ren, Ruijin Hospital
- Investigators
- Yimei Jiang, MD, Study chair, Ruijin Hospitla North
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413930
- Sponsor's protocol ID
- RJ-TaTME-2018
- Status last verified
- Feb 2020
- First submitted
- 22 Jan 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151.
PubMed 26466751Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.
PubMed 25185463Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.
PubMed 26537907
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer
- ClinicalTrials.gov ID
- NCT03413930
- Acronym / sponsor ID
- RJ-TaTME-2018
- Conditions
- Rectal Cancer
- Keywords
- TaTME, Rectal cancer, Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding was raised
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.
Detailed description
Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present，surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TaTME | Experimental | Procedure: Transanal total mesorectal excisionPatients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA） |
| LaTME | Active comparator | Procedure: Laparoscopic total mesorectal excisionPatients with mid or low rectal cancer undergo laparoscopic total mesorectal excision. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years < age < 80 years
- Body mass index (BMI) <30 kg/m2
- Tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection)
- Pathological rectal carcinoma
- Clinically diagnosed cT1-3N0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
Key exclusion criteria (9 listed)
- Requiring a Mile's procedure
- Fecal incontinence
- History of inflammatory bowel disease
- Pregnant woman or lactating woman
- Severe mental disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transanal total mesorectal excisionPatients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA） | Procedure or surgery | TaTME |
| Laparoscopic total mesorectal excisionPatients undergo Laparoscopic total mesorectal excision. | Procedure or surgery | LaTME |
Primary outcome
Circumferential resection margin (CRM)
Time frame: 14 days after surgery
Positive rate of circumferential resection margin (pathological assessment)
11 secondary outcomes
Completeness of mesorectum
Time frame: 14 days after surgery
Lymph node detection
Time frame: 14 days after surgery
Distal safety margin
Time frame: 14 days after surgery
Operative time
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
Length of stay
Time frame: 1-30 days after surgery
Postoperative recovery course
Time frame: 1-14 days after surgery
Early morbidity rate
Time frame: 30 days
Pain score
Time frame: 1-3 days after surgery
3-year disease free survival rate
Time frame: 36 months after surgery
5-year overall survival rate
Time frame: 60 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 26466751Simillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151.
- Background: PubMed 25185463Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.
- Background: PubMed 26537907Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yimei Jiang, MD study chair
Ruijin Hospitla North
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal total mesorectal excision and Laparoscopic total mesorectal excision in people with Rectal Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circumferential resection margin (CRM) (time frame: 14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03413930, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.